BEUDAMED
    22 results · 34ms · Sources: EU EUDAMED, US FDA

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    EXEL SECURETOUCH PTP SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040011881·Zirlux 16+ C2 95X16

    VISION SOURCE

    FDA UDI
    FGX INTERNATIONAL INC.·00193033328958·

    MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    NURSE'S ASSISTANT O.R. CONTROL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VOYAGER NC CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·April 10, 2010

    VOYAGER NC CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·September 1, 2010

    VOYAGER NC CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·September 1, 2010

    VOYAGER RX CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·November 11, 2010

    OPUS MAGNUM2 IMPLANT KNOTLESS FIXATION DEVICE

    FDA Adverse Event
    Other ·ARTHROCARE CORP·Product code MBI·March 3, 2011

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 15, 2014

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 11, 2008

    JOSTENT GRAFTMASTER

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MAF·February 4, 2011

    VOYAGER NC CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·November 11, 2010

    VOYAGER NC CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·November 11, 2010

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·November 5, 2010

    VOYAGER NC CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·June 9, 2010

    VOYAGER NC CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA·Product code LOX·November 24, 2010

    Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37¿C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·August 22, 2018

    CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37¿C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·August 22, 2018